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A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)

Primary Purpose

Alzheimer's Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Bepranemab
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Bepranemab, UCB0107, Phase 2

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 50 to 80 years of age
  • Diagnosis of prodromal/mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD according to National Institute of Aging-Alzheimer's Association (NIA-AA)
  • A global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and CDR-Memory Box (CDRMB) score ≥0.5 at Screening and Baseline
  • Score of ≤85 for the delayed recall domain of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at Screening
  • Mini-Mental State Examination (MMSE) score ≥20 at Screening
  • Participant has an identified informant that has and will maintain sufficient contact (minimum of 5 hours per week) with the participant to be able to provide accurate information on the participant's cognitive, functional, and emotional states and of the participant's personal care
  • At least 6 years of formal education after the age of 5 or work experience to exclude mental deficits other than prodromal or mild AD dementia
  • Evidence of cerebral Aβ accumulation by either positive amyloid assessment by either positron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aβ1-42 ratio assessment

Exclusion Criteria:

  • Any evidence of a condition that may affect cognition other than AD
  • Contraindications to PET imaging
  • Inability to tolerate or contraindication to magnetic resonance imaging
  • Any serious medical condition or abnormality that in the opinion of the investigator would preclude safe participation in and completion of the study or interfere with study assessments and/or study interpretation
  • Alcohol or drug abuse within 2 years of screening
  • Use of any experimental therapy within the past 6 months (or 5 half lives) prior to screening
  • Previous treatment with medication intended to treat a neurodegenerative disorder (other than AD) within 1 year of screening
  • Chronic daily treatment with atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally acting antihistamine or anticholinergic activitiy
  • Received treatment with monoclonal antibodies (mAbs), cytokines, immunoglobulins, or other blood products within 3 months or 5 half-lives (whichever is longer) prior to first dosing

Sites / Locations

  • Ah0003 50428
  • Ah0003 50431
  • Ah0003 50442
  • Ah0003 50458
  • Ah0003 50450
  • Ah0003 50452
  • Ah0003 50447
  • Ah0003 50434
  • Ah0003 50422
  • Ah0003 50467
  • Ah0003 50421
  • Ah0003 50465
  • Ah0003 50449
  • Ah0003 50435
  • Ah0003 50430
  • Ah0003 50429
  • Ah0003 50436
  • Ah0003 50426
  • Ah0003 50427
  • Ah0003 50478
  • Ah0003 50464
  • Ah0003 50438
  • Ah0003 50623
  • Ah0003 50457
  • Ah0003 50454
  • Ah0003 50444
  • Ah0003 50476
  • Ah0003 50446
  • Ah0003 50479
  • Ah0003 50445
  • Ah0003 50453
  • Ah0003 50448
  • Ah0003 50420
  • Ah0003 50451
  • Ah0003 50423
  • Ah0003 50455
  • Ah0003 50380
  • Ah0003 50424
  • Ah0003 50432
  • Ah0003 50440
  • Ah0003 40123
  • Ah0003 40575
  • Ah0003 40576
  • Ah0003 40002
  • Ah0003 50463
  • Ah0003 50461
  • Ah0003 50520
  • Ah0003 50045
  • Ah0003 50291
  • Ah0003 50462
  • Ah0003 50522
  • Ah0003 40129
  • Ah0003 40580
  • Ah0003 40493
  • Ah0003 40635
  • Ah0003 40578
  • Ah0003 40201
  • Ah0003 40581
  • Ah0003 40579
  • Ah0003 40028
  • Ah0003 40430
  • Ah0003 40371
  • Ah0003 40600
  • Ah0003 40597
  • Ah0003 40438
  • Ah0003 40596
  • Ah0003 40598
  • Ah0003 40450
  • Ah0003 40449
  • Ah0003 40601
  • Ah0003 40603
  • Ah0003 40606
  • Ah0003 40605
  • Ah0003 40609
  • Ah0003 40638
  • Ah0003 40608
  • Ah0003 40604
  • Ah0003 40607
  • Ah0003 40602
  • Ah0003 40611
  • Ah0003 40159
  • Ah0003 40160
  • Ah0003 40267
  • Ah0003 40612
  • Ah0003 40105
  • Ah0003 40614
  • Ah0003 40540
  • Ah0003 40615
  • Ah0003 40352
  • Ah0003 40280
  • Ah0003 40049
  • Ah0003 40453
  • Ah0003 40230
  • Ah0003 40613
  • Ah0003 40616
  • Ah0003 40662
  • Ah0003 40619
  • Ah0003 40622
  • Ah0003 40618
  • Ah0003 40621
  • Ah0003 40623
  • Ah0003 40691

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dose level 1 bepranemab

Dose level 2 bepranemab

Placebo Arm

Arm Description

Participants randomized to this arm will receive pre-specified doses (Dose level 1) of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.

Participants randomized to this arm will receive pre-specified doses (Dose level 2) of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.

Participants randomized to this arm will receive Placebo to maintain the blinding during the Double-blind Treatment Period and will re-randomized during the Open-label Extension Period to receive pre-specified doses of bepranemab.

Outcomes

Primary Outcome Measures

Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score
The Clinical Dementia Rating (CDR) scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None=0, Questionable=0.5, Mild=1, Moderate=2, and Severe=3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.

Secondary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.
Incidence of treatment-emergent serious adverse events (TESAEs)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Incidence of TEAEs leading to discontinuation or death
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.tion, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.
Incidence of Drug-related TEAEs
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.
Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale (C-SSRS) is a measure used to identify and assess individuals at risk for suicide. The C-SSRS is made up of ten categories, all of which maintain binary responses (yes/no) to indicate a presence or absence of the behavior. The ten categories included in the C-SSRS are as follows: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide.
Change from Baseline to Week 56 and Week 80 on indices of tau burden in the brain as measured by [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET)
[18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET) will be used to assess the brain aggregated tau burden during the study. Images will be transferred to and analyzed by a central imaging laboratory. [18F]GTP1 imaging data will be analyzed to determine the standardized uptake value ratio relative to cerebellum in multiple brain regions.
Change from Baseline to Week 56 and Week 80 in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) is a composite scale (neuropsychological test battery and clinician reported outcome) that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. Higher scores indicate greater impairment, with a minimum of 0 and a maximum of 90.
Change from Baseline to Week 56 and Week 80 in Amsterdam-Instrumental Activities of Daily Living (A-iADL)
The Amsterdam-Instrumental Activities of Daily Living Questionnaire (A-iADL) is an adaptive and computerized observer-reported outcome measure designed to assess impairments in instrumental activities of daily living (iADL) in early dementia. The questionnaire is administered to an informant such as a relative or friend, with every effort made to use the same informant for a particular study participant throughout the study. The questionnaire consists of 70 items in 7 categories, which takes approximately 20 to 25 minutes to complete. The A-iADL assesses impairments in a broad range of daily activities including household activities, household appliances, finances, work, computer, appliances, leisure activities. The scoring range is 20 to 80 using an item response theory algorithm, with higher scores indicating better functioning (Sikkes et al, 2013).
Change from Baseline to Week 56 and Week 80 in Mini-Mental State Examination (MMSE) total score
The MMSE is an 11-item neuropsychological test that is used to assess cognitive status in adults, and can be used to screen for cognitive impairment and to estimate severity of cognitive impairment. It assesses orientation, memory, attention, ability to name, ability to follow verbal and written commands, ability to write a sentence and to copy a drawing. The test takes approximately 10 to 15 minutes to complete. The score ranges from 0 to 30. Lower scores are indicative of poorer cognitive performance.
Serum concentrations of bepranemab over the 80-week Double-blind Treatment Period
Serum samples will be collected for the measurement of concentrations of bepranemab at different time points during the Double-blind Treatment Period.

Full Information

First Posted
April 27, 2021
Last Updated
October 12, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT04867616
Brief Title
A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)
Official Title
A Patient- and Investigator-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Study Participants With Prodromal to Mild Alzheimer's Disease (AD), Followed by an Open-Label Extension Period
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
May 20, 2024 (Anticipated)
Study Completion Date
July 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer's Disease (AD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, Bepranemab, UCB0107, Phase 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Upon completion of the 80-week Double-blind Treatment Period, study participants will be eligible to enter a 48-week Open-label Extension Period with planned treatments of bepranemab for 44 weeks, followed by a Safety Follow-up Visit 20 weeks after the last infusion of investigational medicinal product.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
421 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose level 1 bepranemab
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive pre-specified doses (Dose level 1) of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.
Arm Title
Dose level 2 bepranemab
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive pre-specified doses (Dose level 2) of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Participants randomized to this arm will receive Placebo to maintain the blinding during the Double-blind Treatment Period and will re-randomized during the Open-label Extension Period to receive pre-specified doses of bepranemab.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: Solution for infusion Route of administration: Intravenous infusion Participants will receive Placebo during the Double-blind Treatment Period.
Intervention Type
Biological
Intervention Name(s)
Bepranemab
Intervention Description
Pharmaceutical form: Solution for infusion Route of administration: Intravenous infusion Participants will receive pre-specified doses of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.
Primary Outcome Measure Information:
Title
Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score
Description
The Clinical Dementia Rating (CDR) scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None=0, Questionable=0.5, Mild=1, Moderate=2, and Severe=3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.
Time Frame
From from Baseline to Week 80
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.
Time Frame
From Baseline to the Safety Follow-Up (Week 152)
Title
Incidence of treatment-emergent serious adverse events (TESAEs)
Description
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time Frame
From Baseline to the Safety Follow-Up (Week 152)
Title
Incidence of TEAEs leading to discontinuation or death
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.tion, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.
Time Frame
From Baseline to the Safety Follow-Up (Week 152)
Title
Incidence of Drug-related TEAEs
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.
Time Frame
From Baseline to the Safety Follow-Up (Week 152)
Title
Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
The Columbia Suicide Severity Rating Scale (C-SSRS) is a measure used to identify and assess individuals at risk for suicide. The C-SSRS is made up of ten categories, all of which maintain binary responses (yes/no) to indicate a presence or absence of the behavior. The ten categories included in the C-SSRS are as follows: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide.
Time Frame
From from Baseline to Week 80
Title
Change from Baseline to Week 56 and Week 80 on indices of tau burden in the brain as measured by [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET)
Description
[18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET) will be used to assess the brain aggregated tau burden during the study. Images will be transferred to and analyzed by a central imaging laboratory. [18F]GTP1 imaging data will be analyzed to determine the standardized uptake value ratio relative to cerebellum in multiple brain regions.
Time Frame
From from Baseline to Week 56 and Week 80
Title
Change from Baseline to Week 56 and Week 80 in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)
Description
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) is a composite scale (neuropsychological test battery and clinician reported outcome) that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. Higher scores indicate greater impairment, with a minimum of 0 and a maximum of 90.
Time Frame
From from Baseline to Week 56 and Week 80
Title
Change from Baseline to Week 56 and Week 80 in Amsterdam-Instrumental Activities of Daily Living (A-iADL)
Description
The Amsterdam-Instrumental Activities of Daily Living Questionnaire (A-iADL) is an adaptive and computerized observer-reported outcome measure designed to assess impairments in instrumental activities of daily living (iADL) in early dementia. The questionnaire is administered to an informant such as a relative or friend, with every effort made to use the same informant for a particular study participant throughout the study. The questionnaire consists of 70 items in 7 categories, which takes approximately 20 to 25 minutes to complete. The A-iADL assesses impairments in a broad range of daily activities including household activities, household appliances, finances, work, computer, appliances, leisure activities. The scoring range is 20 to 80 using an item response theory algorithm, with higher scores indicating better functioning (Sikkes et al, 2013).
Time Frame
From from Baseline to Week 56 and Week 80
Title
Change from Baseline to Week 56 and Week 80 in Mini-Mental State Examination (MMSE) total score
Description
The MMSE is an 11-item neuropsychological test that is used to assess cognitive status in adults, and can be used to screen for cognitive impairment and to estimate severity of cognitive impairment. It assesses orientation, memory, attention, ability to name, ability to follow verbal and written commands, ability to write a sentence and to copy a drawing. The test takes approximately 10 to 15 minutes to complete. The score ranges from 0 to 30. Lower scores are indicative of poorer cognitive performance.
Time Frame
From from Baseline to Week 56 and Week 80
Title
Serum concentrations of bepranemab over the 80-week Double-blind Treatment Period
Description
Serum samples will be collected for the measurement of concentrations of bepranemab at different time points during the Double-blind Treatment Period.
Time Frame
From from Baseline to Week 80

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 to 80 years of age Diagnosis of prodromal/mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD according to National Institute of Aging-Alzheimer's Association (NIA-AA) A global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and CDR-Memory Box (CDRMB) score ≥0.5 at Screening and Baseline Score of ≤85 for the delayed recall domain of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at Screening Mini-Mental State Examination (MMSE) score ≥20 at Screening Participant has an identified informant that has and will maintain sufficient contact (minimum of 5 hours per week) with the participant to be able to provide accurate information on the participant's cognitive, functional, and emotional states and of the participant's personal care At least 6 years of formal education after the age of 5 or work experience to exclude mental deficits other than prodromal or mild AD dementia Evidence of cerebral Aβ accumulation by either positive amyloid assessment by either positron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aβ1-42 ratio assessment Exclusion Criteria: Any evidence of a condition that may affect cognition other than AD Contraindications to PET imaging Inability to tolerate or contraindication to magnetic resonance imaging Any serious medical condition or abnormality that in the opinion of the investigator would preclude safe participation in and completion of the study or interfere with study assessments and/or study interpretation Alcohol or drug abuse within 2 years of screening Use of any experimental therapy within the past 6 months (or 5 half lives) prior to screening Previous treatment with medication intended to treat a neurodegenerative disorder (other than AD) within 1 year of screening Chronic daily treatment with atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally acting antihistamine or anticholinergic activitiy Received treatment with monoclonal antibodies (mAbs), cytokines, immunoglobulins, or other blood products within 3 months or 5 half-lives (whichever is longer) prior to first dosing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ah0003 50428
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Ah0003 50431
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Ah0003 50442
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Ah0003 50458
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Ah0003 50450
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Ah0003 50452
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Ah0003 50447
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ah0003 50434
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Ah0003 50422
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Ah0003 50467
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Ah0003 50421
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Ah0003 50465
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Ah0003 50449
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Ah0003 50435
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Ah0003 50430
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Ah0003 50429
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Ah0003 50436
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Ah0003 50426
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Ah0003 50427
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Ah0003 50478
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Facility Name
Ah0003 50464
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Ah0003 50438
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Facility Name
Ah0003 50623
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Ah0003 50457
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Ah0003 50454
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Ah0003 50444
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Ah0003 50476
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Ah0003 50446
City
Westchester
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Ah0003 50479
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Ah0003 50445
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02184
Country
United States
Facility Name
Ah0003 50453
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Ah0003 50448
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
Facility Name
Ah0003 50420
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Ah0003 50451
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ah0003 50423
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Ah0003 50455
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Ah0003 50380
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Ah0003 50424
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Ah0003 50432
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Ah0003 50440
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Ah0003 40123
City
Brussels
Country
Belgium
Facility Name
Ah0003 40575
City
Brussels
Country
Belgium
Facility Name
Ah0003 40576
City
Kortrijk
Country
Belgium
Facility Name
Ah0003 40002
City
Leuven
Country
Belgium
Facility Name
Ah0003 50463
City
Kelowna
Country
Canada
Facility Name
Ah0003 50461
City
Ottawa
Country
Canada
Facility Name
Ah0003 50520
City
QC
Country
Canada
Facility Name
Ah0003 50045
City
Toronto
Country
Canada
Facility Name
Ah0003 50291
City
Toronto
Country
Canada
Facility Name
Ah0003 50462
City
Toronto
Country
Canada
Facility Name
Ah0003 50522
City
West Vancouver
Country
Canada
Facility Name
Ah0003 40129
City
Bordeaux
Country
France
Facility Name
Ah0003 40580
City
Bron Cedex
Country
France
Facility Name
Ah0003 40493
City
Marseille
Country
France
Facility Name
Ah0003 40635
City
Nantes
Country
France
Facility Name
Ah0003 40578
City
Paris
Country
France
Facility Name
Ah0003 40201
City
Rennes
Country
France
Facility Name
Ah0003 40581
City
Toulouse
Country
France
Facility Name
Ah0003 40579
City
Villeurbanne
Country
France
Facility Name
Ah0003 40028
City
Berlin
Country
Germany
Facility Name
Ah0003 40430
City
Munich
Country
Germany
Facility Name
Ah0003 40371
City
Monza
Country
Italy
Facility Name
Ah0003 40600
City
Parma
Country
Italy
Facility Name
Ah0003 40597
City
Pavia
Country
Italy
Facility Name
Ah0003 40438
City
Roma
Country
Italy
Facility Name
Ah0003 40596
City
Rome
Country
Italy
Facility Name
Ah0003 40598
City
Rome
Country
Italy
Facility Name
Ah0003 40450
City
Amsterdam
Country
Netherlands
Facility Name
Ah0003 40449
City
Den Bosch
Country
Netherlands
Facility Name
Ah0003 40601
City
Zwolle
Country
Netherlands
Facility Name
Ah0003 40603
City
Bialystok
Country
Poland
Facility Name
Ah0003 40606
City
Bydgoszcz
Country
Poland
Facility Name
Ah0003 40605
City
Katowice
Country
Poland
Facility Name
Ah0003 40609
City
Katowice
Country
Poland
Facility Name
Ah0003 40638
City
Scinawa
Country
Poland
Facility Name
Ah0003 40608
City
Szczecin
Country
Poland
Facility Name
Ah0003 40604
City
Warsaw
Country
Poland
Facility Name
Ah0003 40607
City
Warsaw
Country
Poland
Facility Name
Ah0003 40602
City
Warszawa
Country
Poland
Facility Name
Ah0003 40611
City
Wroclaw
Country
Poland
Facility Name
Ah0003 40159
City
Barcelona
Country
Spain
Facility Name
Ah0003 40160
City
Barcelona
Country
Spain
Facility Name
Ah0003 40267
City
Barcelona
Country
Spain
Facility Name
Ah0003 40612
City
Barcelona
Country
Spain
Facility Name
Ah0003 40105
City
Cordoba
Country
Spain
Facility Name
Ah0003 40614
City
Donostia
Country
Spain
Facility Name
Ah0003 40540
City
Madrid
Country
Spain
Facility Name
Ah0003 40615
City
Madrid
Country
Spain
Facility Name
Ah0003 40352
City
Pamplona
Country
Spain
Facility Name
Ah0003 40280
City
Sant Cugat Del Valles
Country
Spain
Facility Name
Ah0003 40049
City
Sevilla
Country
Spain
Facility Name
Ah0003 40453
City
Terrassa
Country
Spain
Facility Name
Ah0003 40230
City
Valencia
Country
Spain
Facility Name
Ah0003 40613
City
Valencia
Country
Spain
Facility Name
Ah0003 40616
City
Zaragoza
Country
Spain
Facility Name
Ah0003 40662
City
Birmingham
Country
United Kingdom
Facility Name
Ah0003 40619
City
Bristol
Country
United Kingdom
Facility Name
Ah0003 40622
City
Guildford
Country
United Kingdom
Facility Name
Ah0003 40618
City
London
Country
United Kingdom
Facility Name
Ah0003 40621
City
London
Country
United Kingdom
Facility Name
Ah0003 40623
City
Plymouth
Country
United Kingdom
Facility Name
Ah0003 40691
City
Winchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of reidentifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
http://www.Vivli.org

Learn more about this trial

A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)

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